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Compoglass® F Compoglass® Flow

Scientific Documentation

Scientific Documentation Compoglass F / Compoglass Flow of 26

TABLE OF CONTENT

1. Introduction 4 1.1 Requirements Placed on a Restorative Material 4

1.1.1 Working requirements 4 1.1.2 Physical and chemical requirements 4 1.1.3 Clinical requirements 4 1.1.4 Toxicological requirements 4

1.2 Properties of Glass Ionomers 5 1.3 Properties of Composites 5

2. Chemistry of Restorative Materials 6 2.1 Glass Ionomers 6 2.2 Composites 6 2.3 Compomers 7 2.4 Compoglass™ 7 2.5 Compoglass® F 8 2.6 Compoglass® Flow 8

3. Technical Data Sheet 9

4. Physical Properties of Compoglass F 11 4.1 Fluoride release 11 4.2 Wear 12 4.3 Bonding with Dentin and Enamel 13 4.4 Marginal Adaptation in Mixed Class V Cavity Preparations 13 4.5 Radiopacity According to ISO 4049 13 4.6 Surface Roughness 15 4.7 Other Physical Data 15

5. Scientific Studies on Compoglass 16 5.1 In Vitro Investigation (Physical Measurements) 16

5.1.1 Bonding strength 16 5.1.2 Release of Fluoride Ions 16 5.1.3 Wear Simulation 17 5.1.4 Hardness 17

5.2 In Vivo Investigations (Clinical Investigations) 17 5.2.1 Class V 17 5.2.2 Deciduous Teeth 18 5.2.3 Long-Term Temporaries 19

6. Biocompatibility 20 6.1 Acute Oral Risk 20 6.2 Histology 20 6.3 Sensitization 20 6.4 Mutagenicity 21 6.5 Cytotoxicity 21

7. Literature 22


Summary Compoglass was introduced on the occasion of IDS 1995 in Cologne and was the second compomer available. It was well-accepted by the market. Various independent studies have rated Compoglass an excellent product superior to competitive materials. With Compoglass F, we are now offering a yet improved compomer version.

Compoglass F - what has been improved?

• The fluoride release has again been increased

• The surface is yet again smoother

• The marginal adaption has again been improved

• The matrix has been optimized

Advantages of Compoglass F over Compoglass

• The increased fluoride release reduces the risk of developing secondary caries. Compoglass F is thus used in cases with particularly high caries risk and where secondary caries often occurs, i.e. restorations in deciduous teeth and cervical defects.

• The extremely smooth surface features improved polishability and is less prone to palque accumulation.

• The improved marginal adaption results in tighter margins. Therefore, marginal discolouration and marginal caries are less likely to occur.

• The matrix has been optimized with regard to the influence on fluoride release and stability.


1. Introduction Today's patients are no longer satisfied with the purely functional restoration of defective tooth structure. Patient requirements for tooth-coloured restorations cannot be adequately satisfied with glass ionomer cements. Although today's composites offer all the aesthetic possibilities desired, they frequently require more time-consuming working techniques by the dentist. Taking these aspects into account, the new compomer materials (Krejci, 1993) combine the desirable properties of the two restorative materials. Working with compomers is quick and easy. Furthermore, they satisfy the demand for outstandingly aesthetic, cosmetic restorations.

1.1 Requirements Placed on a Restorative Material

A restorative material must meet a variety of requirements (Janda, 1988, a, b, c):

1.1.1 Working requirements

easy shade selection

optimum consistency (handling)

high polishability

1.1.2 Physical and chemical requirements

good mechanical properties

limited or no solubility

limited or no shrinkage

1.1.3 Clinical requirements

excellent resistance to oral conditions

good shade matching with natural tooth structure

good stability of shade

wear resistance similar to that of tooth enamel

sufficient radiopacity

excellent adaptation to preparation margins and bonding with tooth substance

fluoride release

1.1.4 Toxicological requirements

lowest possible toxicological risk

biocompatibility


1.2 Properties of Glass Ionomers

☺ direct adherence to enamel and dentin

☺ long-term release of fluoride ions, which are absorbed by the adjacent tooth structure

☺ biocompatibility

☺ easy working technique

unsatisfactory wear resistance

variations in the liquid/powder ratio influence properties

sensitivity to moisture during curing

weaker bond with dentin than materials combined with special dentin adhesives

insufficient aesthetics

mixing required

highly limited clinical indication

1.3 Properties of Composites

☺ excellent physical properties

☺ high wear resistance

☺ polishability

☺ good aesthetics

☺ good resistance to oral conditions

no direct bonding with enamel and dentin

polymerization shrinkage of 2-5 % (volume)

time-consuming, sensitive working technique

rubber dam recommended

Ivoclar Vivadent has combined the favourable properties of both materials in one new restorative. The following detailed examination of the chemistry of the different restorative materials is intended to clarify the synthesis.

Summary: A new restorative material combining the favourable properties of glass ionomers and composites is desirable.


2. Chemistry of Restorative Materials

2.1 Glass Ionomers

Composition: Aluminium fluorosilicate glass Polycarboxylic acid Curing reaction: Acid-base reaction, complex formation

2.2 Composites

Composition: Monomer with curable double bonds Filler Photoinitiator

Curing reaction: Radical polymerization


2.3 Compomers1

Composition: Aluminium fluorosilicate glass Dicarboxylic acid with curable double bonds Photoinitiator Monomer with free double bonds

Curing reaction: 1. Radical polymerization (composite reaction) 2. Acid-base reaction (glass ionomer reaction)

Various manufacturers have tried to combine the properties of both composites and glass ionomers. The development of light-curing glass ionomers and compomers (Photac Fil, Fuji II LC, Vitremer, Dyract) simplified the working techniques for this class of materials. Fluoride release, however, was significantly reduced (Torebzadeh et al., 1994) and the strength (Watts et al., 1994; Knobloch and Kerby, 1994) and wear resistance values (Peters et al., 1996) of composite materials were still not reached.

2.4 Compoglass™

Composition: Aluminium fluorosilicate glass (∅ grain size 1.5 μm) Dicarboxylic acid with curable double bonds 2 Filler based on composite technology Photoinitiator Monomer with free double bonds

Curing reaction: 1. Radical polymerization (composite reaction) 2. Acid-base reaction (glass ionomer reaction)

1 Krejci, 1993 2 Chemical strengthening of monomers (cycloaliphatic backbone = increased toughness), DCDMA

monomer


2.5 Compoglass® F

Composition: Very fine aluminium fluorosilicate glass (Ø grain size 1.0 µm) Dicarboxylic acid with polymerizable double bonds 3 Filler based on composite technology Photoinitiator Modified monomer with free double bonds

Curing reaction: 1. Radical polymerization (composite reaction) 2. Acid-base reaction ( glass ionomer reaction)

The following requirements had to be met in the development of a new filler:

Aluminium fluorosilicate glass with adequate physical strength and fluoride release

A monomer with a tough backbone containing double bonds as well as supporting acid groups

A filler mixture giving the material the desired physical properties

Compoglass F is the first restorative material to satisfy all these requirements. Compoglass F releases fluoride from three different sources: aluminium fluorosilicate glass, inorganic fluorides in the adhesive, and ytterbium trifluoride (ytterbium trifluoride, for which Ivoclar Vivadent owns a worldwide patent, has been clinically successful for more than 10 years). Wear resistance and strength have been achieved by chemically strengthening the monomers (cycloaliphatic DCDMA monomer; cycloaliphatic backbone = increased toughness) and adding an additional filler from the field of composite technology (spherosil).

Summary: Compoglass F is the first real hybrid between glass ionomers and composites.

2.6 Compoglass® Flow

Compoglass Flow und Compoglass F are based on the same compomer chemistry. The flow properties of Compoglass Flow have been developed to meet the indications and requirements of compomers. As a result, Compoglass Flow features a new kind of flowability. The material is injected directly into the cavity. Given its flowability, Compoglass Flow easily adapts to the cavity walls without the use of additional instruments.

☺ reliable self-adaptation

☺ no material flowing away

☺ no trapping of air

☺ excellent marginal seal

3 Chemical reinforcement of the monomers (Cyclo compound = increased stability), DCDMA

monomer


3. Technical Data Sheet

Compoglass® F Light curing, compomer-based restorative material

Standard - Composition: (in weight %)

Urethane dimethacrylate 11.5

Polyethylene glycoldimethacrylate 4.6

Cycloaliphat. dicarbonic acid dimethacrylate 6.6

Mixed oxide, silanized 5.9

Ytterbiumtrifluoride 11.5

Ba-Al-Fluorosilikateglass, silanized 59.6

Catalysts, Stabilizers and Pigments 0.3 Physical properties:

In accordance with ISO 4049 and ISO 9917

Flexural strength 110 MPa

Flexural modulus 8200 MPa

Compressive strength 285 MPa

Vickers hardness 550 MPa

Water absorption 39 µg/mm3

Water solubility 0.25 µg/mm3

Radiopacity 275 % Al

Depth of cure (shade Universal) > 4.5 mm

Sensitivity to ambient light > 100 sec.


Compoglass® Flow Light curing, compomer-based restorative material Standard -Composition: (in weight %) Urethane dimethacrylate 20.6

Polyethylene glycoldimethacrylate 6.6

Cycloaliphat. dicarbonic acid dimethacrylate 5.7

Mixed oxide, silanized 5.1

Ytterbiumtrifluoride 10.0

Ba-Al-Fluorosilikateglass, silanized 51.7

Catalysts and Stabilizers 0.3

Pigments < 0.1 Physical properties: In accordance with ISO 4049 and ISO 9917 Flexural strength 95 MPa

Flexural modulus 5000 MPa

Compressive strength 325 MPa

Vickers hardness 310 MPa

Water absorption 35 µg/mm3

Water solubility Ø µg/mm3

Radiopacity 230 % Al

Depth of cure (shade Universal) > 4.5 mm

Sensitivity to ambient light > 95 sec.


4. Physical Properties of Compoglass F Compoglass F stands out because of the following features: ☺ easy, quick working technique

☺ high degree of fluoride release

☺ minimal wear

☺ strong bond with dentin and enamel

☺ tight marginal seal

☺ low shrinkage

☺ impressive aesthetics

☺ radiopacity

☺ smooth, polishable surface

☺ easy-to-handle, watery adhesive free from acetone

The physical properties of different restorative materials are presented in the following pages to show the benefits of Compoglass F compared with other compomers and light-curing glass ionomers, as well as to give dentists a suggestion of where to position Compoglass with regard to composites and glass ionomers.

4.1 Fluoride release

Cumulative fluoride release from test samples was established in a Tris-lactate buffer (pH 7.2). Additional fluoride release from the Syntac Single Component adhesive was not taken into consideration. Fluoride release of compomers during 4 weeks.

0

5

10

15

20

25

30

35

Co mpo mer B Co mpo mer C Co mpo mer D Co mpo mer A Co mpo glas s Co mpo glas s F

Fluo

ride

rele

ase

[µg/

cm²]

In-house investigation, R&D Ivoclar Vivadent Schaan, Liechtenstein

Conclusion: The fluoride release of Compoglass F was increased by 50 % compared with that of Compoglass.


4.2 Wear

The materials were subjected to a combined stress test that consisted of toothbrush and toothpaste wear, rapid temperature changes, and cyclical occlusal stress. The five-year values correspond to 300 minutes of brushing teeth, 1,200,000 masticatory cycles (49N / 1.7 Hz), and 3,000 thermal cycles (5-55°C).

0

100

200

300

400

500

600

700

800

0 1 2 3 4 5[In-vivo-equivalente years]

wea

r [µm

]

Compoglass

Compoglass F

Compomer A

Glasionomer A

Glasionomer B

Heliomolar RO

Tetric

In-house investigation , R&D Ivoclar Vivadent Schaan, Liechtenstein

Conclusion: The smaler particle size of the filler of Compoglass F (aluminium fluorosilicate glass 1.0 µm) improves the wear resistance compared to Compoglass (aluminium fluorosilicate glass 1.5 µm).


4.3 Bonding with Dentin and Enamel

Shear bond strength was established with bovine teeth.

In-house investigation, R&D Ivoclar Vivadent Schaan, Liechtenstein [Compo=Compoglass / Compo F=Compoglass F / Syntac SC = Syntac Single-Component]

Conclusion: The high bonding values on enamel are a prerequiste for tight marginal seals. The values were achieved with acid etching.

4.4 Marginal Adaptation in Mixed Class V Cavity Preparations

0

10

20

30

40

50

60

70

80

90

1 h 1 d 30 d

Perf

ect m

argi

n [%

]

Compoglass Compoglass F

Interne Untersuchung, F&E Ivoclar Vivadent Schaan, Liechtenstein

Fazit: The modification of Compoglass F improves marginal quality. Close margins show less tendency for discolouration and caries.

4.5 Radiopacity According to ISO 4049

For restorations in areas that are clinically difficult to reach or even inaccessible, an X-ray of a radiopaque restoration is the only non-invasive means of diagnosing secondary caries. Radiopacity also offers an easy method for documenting the dentist's work.


0

50

100

150

200

250

300

Co mpo mer B Co mpo mer A Co mpo g lass Comp og lass F

Rad

iopa

city

[% A

l]

In-house investigation, R&D Ivoclar Vivadent Schaan, Liechtenstein

Conclusion: The radionpacity of Compoglass is achieved by adding ytterbium trifluoride (ytterbium trifluoride, for which Ivoclar Vivadent owns a worldwide patent, has been clinically successful for more than 10 years.


4.6 Surface Roughness

Smooth surfaces are a prerequisite for an aesthetic appearance. Furthermore, they are less susceptible to plaque accumulation than rough surfaces.

The compomers examined were polymerized under a foil and subsequently polished with the indicated instrument. The test samples were polished either with Hawe finishing and polishing disks, or with Politip P rubber polishers from Ivoclar Vivadent.

0

0.5

1

1.5

2

2.5

3

3.5

Ra [µm]Hawe

polishingdisks*

Rt [µm]Hawe

polishingdisks*

Ra [µm]Vivadent

silicone rubberpolisher

Rt [µm]Vivadent

silicone rubberpolisher

Rou

ghne

ss d

epth

[µm

]

Compoglass Compoglass F Compomer A Compomer B

Rzanny and Welker (1997), University of Jena, Germany * The test samples were treated with Hawe coarse, medium, fine and x-fine. The diagram

indicates the average values.

Ra mean roughness depth / Rt maximum roughness depth

Conclusion: The smooth surface of Compoglass is achieved with the fine particle size of the filler. The mean grain size of the fluoro-aluminium silicate glass was reduced from 1.5 µm in Compoglass to 1.0 µm in Compoglass F.

4.7 Other Physical Data Compoglas

s F Compogla

ss Compome

r A Compome

r B Compome

r C Compome

r D

Flexural strength*1 [MPa] 110 105 115 135 160 133

Modulus of elaasticity *1 [MPa]

8200 8700 7700 11400 17500 12900

Compressive strength * [MPa]

285 260 225 261

Vickers hardness * [MPa] 550 510 470

Water solubility *1 0.25 µg/mm3

Water absorption *1 39 µg/mm3 0.33 % 0.47 %

*=after 24h, H2O, 37 °C / 1=according to ISO 4049


5. Scientific Studies on Compoglass A large number of independent studies have been conducted on Compoglass since its introduction at IDS 1995 in Cologne. It has been rated an excellent product superior to competitive products. These studies will be summarized below.

5.1 In Vitro Investigation (Physical Measurements)

5.1.1 Bonding strength

Title Results [in MPa] Reference Long-term bond on dentin • after 1h: Compoglass 29.5, Dyract 29.7

• after 6 weeks: Compoglass 31.4, Dyract 25.3 Jakob et al., 1996

Bonding strength on enamel

• without enamel etching: Dyract 11.2, Compoglass 17.9

• with enamel etching: Dyract 33.6, Compoglass 32.1

Moll et al., 1996

Bond on enamel and dentin • Enamel: Dyract 13.5, Compoglass 18.2 • Dentin: Dyract 18.9, Compoglass 18.4

Leach and Aboush, 1996

Bond on dentin • Compoglass 16.29, Fuji II LC 15.42, Dyract 15.33 Garcia-Godoy et al., 1996

Bond on dentin • Photac Fil 0.5, Ketac Fil 3.0, Ketac Silver 3.1, Vitremer 7.9, Fuji II LC 8.2, Dyract 9.8, Compoglass 13.7

Peutzfeld 1996

Bond on deciduous teeth • Herculite Optibond 6.07, Dyract 8.67, Compoglass 11.94

Jumlongras and White, 1997

Bond on enamel with and without acid etching

• Without acid etching: Compoglass 6.9, Dyract 4.5 • 20 s acid etching: Compoglass 22.4 Dyract 16.0 • 40 s acid etching: Compoglass 18.1, Dyract 14.8

Buchalla et al., 1997

5.1.2 Release of Fluoride Ions

Title Results Reference Fluoride release in an acidous or neutral environment

• neutral pH [µg/cm2] Vivaglass Base 49, Dyract 52, Compoglass 98

• acidous pH [µg/cm2]: Vivaglass Base 54, Dyract 87, Compoglass 113

Attin et al., 1996

Fluoride release during 6 months

• [µg/mm2d] Ketac Fil 0.11, Compoglass 0.05, Chem Fil Superior 0.03, Dyract 0.02

Shaw and McCabe, 1997

Fluoride release of glass ionomers, compomers, and composites

• After 1 day [ppm]: Fuji II LC 63.8, Fuji II 54.6, Vitremer 54.4, Compoglass 30.9, Dyract 27.2, Heliomolar 13.6

• After 44 days [ppm]: Fuji II LC 16.7, Fuji II 11.3, Vitremer 12.2, Compoglass 17.0, Dyract 6.2, Heliomolar 3.5

Nunez et al., 1997

Fluoride release of compomers and flowable composites

• After 1 week [ppm]: Compoglass 9.77, Dyract 1.84, Crystal 7.71, Ultraseal XT 0.71, Flow It 0.42

• After 1 month [ppm]: Compoglass 2.56, Dyract 1.07, Crystal 1.03, Ultraseal XT 0.20, Flow It 0.00

• After 8 months [ppm]: Compoglass 0.98, Dyract 0.93, Crystal n/t, Ultraseal XT n/t, Flow It 0.00

Rasmussen et al., 1997


5.1.3 Wear Simulation

Title Results Reference Abrasion of silicophosphate and glass ionomer cements

• Drala stone cement (highest abrasion) > Drala steel cement >Cupro Dur > Trans Lit > Ketac Silver > Fuji IX > Dyract > Compoglass > Valiant (least abrasion)

Bauer et al., 1996

5.1.4 Hardness

Title Results Reference Surface hardness of glass ionomers and compomers

• Rockwell hardness: Vitremer 14.1, Photac Fil 14.4, Fuji II LC 27.7, Fuji IX 35.5, Dyract 38.9, Compoglass 44.4, Z100 62.6

Peutzfeld et al., 1997

Microhardness • Vickers hardness: Compoglass 68.8, Fuji II LC 62.7 Dyract 57.7, Vitremer 50.0

Ellakuria et al., 1996

5.2 In Vivo Investigations (Clinical Investigations)

5.2.1 Class V

Head of Study Subject Experimental Status/Results Dr. U. Blunk, T. Richter, ZA / Prof. J.F. Roulet Centre for Dentistry at the Charité Humboldt University, Berlin, Germany

Clinical testing of Compoglass and a comparable product (Product A) for the restoration of cervical cavities

One hundred teeth with non-carious cavities are being studied. The cavities were cleaned with a polishing paste. Subsequently, they were isolated and restored with one of the materials tested. Immediately following their placement and after 6, 12, 24, and 36 months, the restorations are evaluated with direct clinical methods and the quality of the margins are examined with the help of SEMs.

All restorations have been placed and were examined after 6 months. A corresponding publication is being prepared..

Prof. R.D. Perry/ Prof. G. Kugel Department of Restorative Dentistry Tufts University, Boston, USA

Evaluation of the clinical performance of Compoglass in Class V restorations

The cavities are prepared without mechanical retention. A total of 63 restorations are placed. The teeth are evaluated according to clinical parameters after 6, 12, 24, and 36 months. In addition, close-up colour photographs and X-rays will be used to conduct indirect evaluations

Initially, 100 % of the restorations were rated A with regard to all criteria. The 6-month examination was already conducted on 19 restorations. All of them scored A ratings.

Dr. A. Abdalla Dr. H. Alhadainy Dr. F. Garcia-Godoy, Tanta Egypt and Department of Pediatric and Restorative Dentistry University of Texas, San Antonio, USA

Clinical investigation on glass ionomers (Fuji II LC and Vitremer) and compomers (Dyract and Compoglass) for the restoration of carious Class V defects

30 Class V cavities each were restored with 4 different materials. After 1 and 2 years, the restorations were evaluated according to USPHS criteria.

After 1 year, the shade match of Vitremer was significantly weaker than that of the other materials tested. After 2 years, the compomers demonstrated clearly better results than Fuji II LC, which was rated higher than Vitremer. Abdalla et al., 1997


5.2.2 Deciduous Teeth

Head of Study Subject Experimental Status/Results Dr. A. Trummler Director of the School Dental Service of the City of St. Gallen Switzerland

Clinical evaluation of Compoglass as a restorative material for deciduous teeth.

103 Compoglass restorations were placed in 64 patients and evaluated over a period of 2 years.

Initially, all restorations were rated A (A=good; B = clinically acceptable; C=unacceptable). One hundred restorations were examined after 12 months. 97 % were rated A and 3 % B. The shade was considered as good in all cases. Neither postoperative sensitivity nor secondary caries were noted. After 24 months, 93 restorations were examined (94.6% A, 5.4 % B / shade 99% A, 1% B / postoperative sensitivity 0% / secondary caries 0%).

Prof. F. Garcia-Godoy Department of Pediatric Dentistry and Restorative Dentistry University of Texas, San Antonio, USA

Clinical investigation of Compoglass as a restorative for Class I and II cavities in primary molars

Sixty restorations were inserted in deciduous molars. The teeth are evaluated after 6, 12, 18, and 24 months according to clinical parameters (USPHS). In addition, close-up colour photographs and impressions will be made for the indirect evaluation of the restorations.

After 6 months, the restorations were rated perfect (marginal quality (100% A), discolouration (100% A), anatomic shape (100% A), shade match 100% A). After 12 months, only the ratings for marginal quality (98% A) and discolouration (98% A) were slightly different. Neither postoperative sensitivity nor secondary caries were noted.


5.2.3 Long-Term Temporaries

Head of Study Subject Experimental Status/Results Prof. E. Reich/ A. Zamani, ZA Department for Periodontology and Operative Dentistry University of Saarland, Homburg, Saar, Germany

Clinical evaluation of Compoglass, with and without the acid etch technique, in stress bearing occlusal Class I and II cavities

Patients with at least two similar cavities (Class I or II) were selected to participate in the study. In general, the cavities were prepared according to the adhesive technique. One cavity for each patient was restored with Compoglass, according to the Instructions for Use and without using the acid etch technique. In 20 patients, the second cavity was restored with a comparable material (Dyract) and in 20 patients with Compoglass using the acid etch technique. The teeth will be evaluated according to clinical parameters after 6, 12, 18, and 24 months. In addition, close-up colour photographs will be taken. Impressions will be made of some of the restored teeth to determine abrasion.

After 6 months, the restorations were examined according to modified Ryge critera. All restorations were functional. Neither discolouration of the restorations, nor secondary caries were noted. After 6 months, 75 % of the Dyract restorations and 73 % of the Compoglass restoration showed slight negative steps, but no marginal gaps. When seated with acid etching, Compoglass restorations did not demonstrate any changes of marginal quality. 33 % of the Dyract restorations and 7 % of the Compoglass restorations evidenced marginal discolouration after 6 months. Restorations seated with acid etching did not show any marginal discolouration (Balz et al., 1997).


6. Biocompatibility Compoglass F consists of the same component as the existing Compoglass. Only the ratio of the components has been optimized. Furthermore, the fluorosilicate glass was finer ground. Toxicological data are available for the individual components. Given the extremely similar composition, the toxicological data of Compoglass may be used for the toxicological evaluation of Compoglass F. Additionally, a cytotoxicity test was conducted on Compoglass F. The following examinations are necessary for evaluating the biocompatibility of dental materials:

1. Acute oral risk: The patient accidentally swallows the entire amount of adhesive and restorative material

2. Local tolerance with surrounding tissue that comes in contact with the material

3. Possible sensitizing reactions

4. Mutagenic potential of eluted low-molecular components

5. Cytotoxicity: Damage to cultivated cells

6.1 Acute Oral Risk

Acute oral toxicity is established from the relationship between dose and effect, tested on rodents. The measure for the toxic effect was established as the lethal dose (LD50 value).

The following LD50 values can be calculated from the experimental data:

Compoglass > 5000 mg / kg

Syntac Single-Component > 5000 mg / kg

Acute toxicological risk of Compoglass and Syntac Single Component can thus be virtually excluded.

6.2 Histology

Local tolerance with surrounding tissue was tested on monkeys. The restorative was placed in Class V cavities using the adhesive technique. The effect on vital pulp tissue was examined. Infections or inflammations were not observed at any time (Tarim et at., 1996, 1997).

This study proves that Compoglass, used together with Syntac Single Component, does not harm the pulp. Rather Compoglass effectively protects the pulp against bacteria and inflammation.

6.3 Sensitization

Sensitization means that heightened sensitivity or allergic reactions to the chemical substance are induced. The sensitizing potential of a chemical substance was tested on the skin of albino guinea pigs.

No allergic reactions toward Compoglass were observed under the given test conditions. Compoglass can thus be considered non-sensitizing.


6.4 Mutagenicity

Mutagenicity of a substance can be easily and reliably determined with a bacterial test (Ames Test, Ames et al., 1975).

No mutation of Salmonella typhimurium could be determined in an Ames Test conducted under the selected experimental conditions. In these tests, Compoglass was demonstrated to be non-mutagenic.

6.5 Cytotoxicity

The toxicity of eluted low-molecular substances can be determined with cultivated cells of mammals.

No cytotoxicity was determined for Compoglass F.


7. Literature Ames BN, Mccann J, Yamasaki E Methods for detecting carcinogens and mutagens with the Salmonella / mammalien-microsome mutagenicity test Mutation Research 31 (1975), 347-364 De Gee AJ, Pallav P, Davidson CL Effect of abrasion medium on wear of stress-bearing composites and amalgum in vitro J Dent Res 65 (1986) 654-658 Finger W, Thiemann J Correlation between in vitro and in vivo wear of posterior restorative materials Dent Mat 3 (1987) 280-286 Janda R Der Stand der Entwicklung auf dem Gebiet der Zahnfüllungskunststoffe (I) Quintessenz 39 (1988), 1067-1073 Janda R Der Stand der Entwicklung auf dem Gebiet der Zahnfüllungskunststoffe (II) Quintessenz 39 (1988), 1243-1253 Janda R Der Stand der Entwicklung auf dem Gebiet der Zahnfüllungskunststoffe (III) Quintessenz 39 (1988), 1393-1396 Knobloch L, Kerby, R E

Physical properties of light-cure and conventional glass ionomer cements J Dent Res 73 (1994), IADR Abstract Nr. 938 Krejci I Standortbestimmung in der konservierenden Zahnmedizin Schweiz Monatsschr Zahnmed 103 (1993), 614-624 Peters TCRB, Roeters JJM, Frankenmolen FWA Clinical evaluation of Dyract in primary molars: 1-year results Am J Dent 9 (1996) 83-87 Torabzadeh H, Aboush YE , Lee AR Comparative assessment of long-term fluoride release from light-curing glass-ionomer cements J Dent Res 73 (1994) 853, Abstract Nr. 531. Watts DC, Bertenshaw BW, Jugdev JS pH and time-dependece of surface degradation in a compomer biomaterial J Dent Res 74 (1995) 912, Abstract Nr. 13.

Veröffentlichungen zu Compoglass: Restoration of class 5 tooth defects - state-of-art 96 CRA Newsletter 20 (1996) 1-2 Compomer easy to use and well accepted CRA Newsletter 10 (1996) 4 Compomers The Dental Advisor 13 (1996) 7 Klinische In-vivo-Untersuchung mit neuem Compomer Compoglass: Erste Resultate fallen zur vollen Zufriedenheit aus DZW 23 (1995) 10 Class V restorative materials Reality Now 76 (1996) 1-3 Abdalla AI, Alhadainy HA, Garcia-Godoy F Clinical evaluation of glass ionomers and compomers in Class V carious lesion Am J Dent 10 (1997) 18-20

Attin T, Kielbassa AM, Plogmann S, Hellwig E Fluoridfreisetzung aus Kompomeren im sauren und neutralen Milieu Dtsch Zahnärztl Z 11 (1996) 675-678 Ausiello P, De Gee AJ, Rengo S, Davidson CL Cusp fracture resistance of endodontically treated adhesively restored upper premolars J Dent Res 76 (1997) 1145 Balz M, Zamani A, Reich E Okklusionstragende Füllungen der Klase I und II mit Kompomeren DGZ (1997) 166-167 Bauer CM, Kunzelmann KH, Hickel R Siliko-Phosphat- und Glasionomerzemente - eine Amalgamalternative? DGZ 1 (1995) 56 Bauer CM, Kunzelmann KH, Hickel R


Silikophsphat- und Glasionomerzemente - eine Amalgamalternative? Dtsch Zahnärztl Z 51 (1996) 339-341 Blunck U Dentinhaftmittel und Kompomere Quintessenz 47 (1996) 19-35 Blunck U Hinweise zur praktischen Anwendung von Kompomeren und Kompositmaterialien in Kombination mit Dentinhaftmitteln Quintessenz 47 (1996) 189-201 Bonte E, Lasfargues JJ, Goldberg M The rat's first molar as an in vivo model for biomaterial testing J Dent Res 76 (1997) 1098 Buchalla W, Attin T, Hellwig E Einfluss der Schmelzätztechnik auf die Haftung von Kompomer-Füllungsmaterialien Dtsch Zahnärztl Z 52 (1997) 463-466 Calabrese M, Graiff L, Brait D, Mason PN Compomer restorations: effect of acid etch on microleakage J Dent Res 76 (1997) 418 Chain JB, Chain MC, Lacefield WR, Russell CM Quantitative microleakage of compomers and a tri-cure glass ionomer cement J Dent Res 76 (1997) 398 Chain JB, Chain MC, Lacefield WR, Russell CM Dentin bond strengths of compomers and a tri-cure glass ionomer cement J Dent Res 76 (1997) 378 Christensen GJ Compomers vs. resin-reinforced glass ionomers J Am Dent Assoc 128 (1997) 479-480 De Gee AJ, Feilzer AJ, Werner A, Davidson CL Wear performance of polyacid modified resin composites J Dent Res 76 (1997) 74 Dietrich T, Lösche AC, Lösche GM, Roulet JF Marginal adaptation of class II sandwich restorations using different light cured GIC's and compomers J Dent Res 76 (1997) 19 Ellakuria J, Triana R, Prado C, Minguez N, Prado J, Cearra P

Microhardness of four light-cured glass ionomer restorative materials J Dent Res 76 (1997) 1135 Fischer J, Marx R Mechanical strength and durability of some newly developed compomers DGZPW 0 (1996) 92 Frankenberger R, Krämer N Die Füllungstherapie im Milchgebiss Phillip J 14 (1997) 169-183 Frankenberger R, Krämer N, Sindel J Haftfestigkeit und Zuverlässigkeit der Verbindung Dentin-Komposite und Dentin-Kompomer Dtsch Zahnärztl Z 51 (1996) 556-560 Frey D, Soglowek W Correlation of abrasion resistance and mechnical properties of compomers J Dent Res 76 (1997) 75 Friedl KH, Schmalz G, Hiller KA, Gottlieb A Bond strength of resin modified glass ionomer cements and compomers J Dent Res 76 (1997) 313 Fröhlich M, Schneider H, Merte K Oberflächeninteraktionen von Dentin und Adhesiv Dtsch Zahnärztl Z 51 (1996) 173-176 Garcia-Godoy F, Rodriguez M, Barberia E Dentin bond strength of fluoride-releasing materials Am J Dent 9 (1996) 80-82 Garcia-Godoy F, Rodriguez M, Barberia E Dentin bond strength of fluoride-releasing materials J Dent Res 75 (1996) 385 Grandgenett C, Donly KJ Caries inhibition of resin-modified glass ionomer cement and compomers J Dent Res 76 (1997) 94 Grant D, Grant G, Suzuki S, Nimer S, Thornton J, Chambliss T, Bradley EL, Cox CF In vitro evaluation of antagonistic wear of compomere systems against human enamel J Dent Res 76 (1997) 423 Hellwig E Fluoridfreisetzung von Kompomeren und Glasionomeren: Im sauren Mileu geben Kompomere mehr Fluoride ab DZW 32 (1996) 12 Hickel R, Kremers L, Haffner C


Kompomere Quintessenz 47 (1996) 1581-1589 Hotz P, Gujer J, Stassinakis A Influence of specimen shape, setting time and glassionomer typ on the long-term fluorid release J Dent Res 75 (1996) 70 Hugenberg A Compoglass - der Amalgamersatz im Milchgebiss? DZW 40 (1995) 13 Jakob M, Haller B, Hofmann N, Klaiber B Long-term Extrusion Shear Bond Strength of Eight Dentin Adhesives J Dent Res 75 (1996) 387 Jodwowska E, Iracki J Shear bond strength of compomers on dentin and enamel J Dent Res 76 (1997) 1146 Johnson ND, Osborne DS, Aguievtseva S, Lynch E Six month fluoride release from seven new restorative materials J Dent Res 75 (1996) 179 Jumlongras D, White GE Bond strength of composite resin and compomers in primary and permanent teeth J Dent Res 76 (1997) 314 Kerby RE, Knoblauch L, Berlin J, Lee J Fracture toughness of glass-ionomer and resin-based restorative materials J Dent Res 76 (1997) 317 Kielbassa AM, Attin T, Wrbas KTH, Dornfeld T, Hellwig E Untersuchungen zur zeitabhängigen Haftung moderner Füllungswerkstoffe auf perfundiertem Milchzahndentin Dtsch Zahnärztl Z 52 (1997) 119-123 Koukopoulou E, Yaman P, Razzoog ME, Efstratopoulou O Color stability of compomers J Dent Res 76 (1997) 323 Krämer N, Pelka M, Kautetzky P, Petschelt A Abrasionsbeständigkeit von Kompomeren und stopfbaren Glasionomerzementen Dtsch Zahnärztl Z 52 (1997) 186-189 Krejci I, Lutz F, Oddera M Aktueller Stand der Kompomere DFZ 9 (1995) 52-57 Lagouvardos P, Apostolopoulos C, Oulis C

Bend strength of repaired hybrid Glass-ionomers Hellenic Dent J 6 (1996) 33-37 Lang H, Schwan R, Nolden R Das Verhalten von Klasse-V-Restaurationen unter Belastung Dtsch Zahnärztl Z 51 (1996) 613-616 Leach H, Aboush YEY The adhesion of Compomers to enamel and dentine J Dent Res 75 (1996) 1130 Leyhausen G, Abtahi M, Karbakhsch M, Sapotnic A, Geurtsen W The biocompatibility of various resin-modified glass-ionomer cements 1st European Union Conference on Glass-ionomers 1 (1996) 41 Lösche AC, Lösche GM, Roulet JF Lichthärtemde Glasionomerzemente und Kompomere zur Versorgung ausgedehnter Klasse-III-Kavitäten Dtsch Zahnärztl Z 51 (1996) 683-686 Lutz F State of the art of tooth-colored restoratives Oper Dent 21 (1996) 237-248 Manz R Sicherung eines umfassenden Behandlungsplans durch ästhetisch ansprechende Interimsversorgung DZW-Special 1 (1996) 36 McSweeney T, Perry R, Aboushala A, Kugel G Different liners in class II composite resin restorations: microleakage study J Dent Res 76 (1997) 424 Medioni E, Sellam S, Rouviere C, Bolla M A confocal microscopy evaluation of three polishing agents for hybrid glass ionomer cement J Dent Res 76 (1997) 39 Meyer JM, Cattani-Lorente MA "Compomers": Between glass ionomer cements and composites 1st European Union Conference on Glass-Ionomers 1 (1996) 32 Moll KH, Haller B, Hofmann N, Klaiber B Phosphoric acid etching and enamel bond of composite/glass ionomer hybrids J Dent Res 75 (1996) 171 Nunez A, Burgess JO, Chan DCN


Fluoride release and uptake of six fluoride releasing restorative materials J Dent Res 76 (1997) 324 Ochsner C, Covey DA, Ewoldsen N, Beatty MW Dental cements/resins containing fluoroaluminosilicate glass: sliding wear and friction coefficients J Dent Res 76 (1997) 421 Osorio R, Rosales JI, Toledano M, Torre Dela FJ, Garcia-Godoy F Water sorption of resins and glass ionomers J Dent Res 76 (1997) 424 Peutzefeldt A, Garcia-Godoy F, Asmussen E Surface hardness and wear of glass ionomers and compomers Am J Dent 10 (1997) 15-17 Peutzfeldt A Compomeres and glass ionomers: bond strength to dentin and mechanical properties Am J Dent 9 (1996) 259-263 Rasmussen TE, Froerer JJ, Hollis RA, Christensen RP Long term fluoride release from compomers and flowable resins J Dent Res 76 (1997) 324 Reich E, Jaeger C, Netuschil L Release and uptake of fluoride by restorative materials J Dent Res 76 (1997) 1099 Salama HS The effect of micro abrasion on surface topography of enamel and esthetic restorative materials Alexandria Dent J 20 (1995) 79-87 Salama HS The influence of the depth of substrate dentin surface and thikness of the current restorative samples on Egypt Dent J 41 (1995) 1513-1516bond strength Salama HS, Kunzelmann KH, Hickel R Shear bond strength of poly acid modified composite (compomer) to dentin Alexandria Dent J 20 (1995) 93-103 Schiffner U, Knop B Ultraschallaktivierte Kompomere zur Fissurenversiegelung? Dtsch Zahnärztl Z 51 (1996) 687-689

Schneider BT, Watanabe LG, Baumann MA, Marshall GW Influence of storage media on microleakage in one-bottle bonding systems J Dent Res 76 (1997) 399 Schütte P Compoglass zur Versorgung von Zahnhalskavitäten ZWR 104 (1995) 0 Shaw AJ, McCabe JF Fluoride release from glass-ionomer and compomer restorative materials Sindel J, Krämer N, Petschelt A Cyclic fatigue of dental glass ionomer cements and compomers J Dent Res 75 (1996) 292 Stassinakis A, Gujer J, Hugo B, Hotz P Fluoridfreisetzung bei konventionellen und modifizierten Glasionomerzementen in vitro Acta Med Dent Helv 1 (1996) 244-249 Stockleben C Postamalgam - neue Möglichkeiten in der Füllungstherapie Swiss Dent 17 (1996) 5-7 Sunoli Periu L Compoglass ? Una nueva generacion de materiales? Informe Dental 1 (1995) 1-3 Tarim B, Suzuki SH, Suzuki S, Hafez AA, Cox CF Histological Pulp response of two compomere systems in class V cavities J Dent Res 75 (1996) 281 Toledano M, Torre Dela FJ, Rosales JI, Osorio R, Garcia-Godoy F Flexural strength evaluation of selected restorative materials J Dent Res 76 (1997) 422 Vichi A, Ferrari M, Davidson CL In vivo microleakage of resin modified glass ionomer cements J Dent Res 76 (1997) 1146 Vijayaraghavan TV, Pak JS Shear bond strength at dentin-cement or adhesive interface using "push out" test mode J Dent Res 76 (1997) 38 Warren DP, Chan JT, Powers JM APF affects surface roughness of hybrid ionomers, compomer and composites


J Dent Res 76 (1997) 75

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